FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOW BACK STRIP (OR) K-BACK
K Number: K912381
·
Decision Jan 30, 1992
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
26
Review Days
246
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Basic Information
- Device Name
- LOW BACK STRIP (OR) K-BACK
- K Number
- K912381
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Katecho, Inc.
- Date Received
- May 29, 1991
- Decision Date
- January 30, 1992
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Katecho, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012404 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 | Oct 12, 2001 | Substantially Equivalent |
| K010543 | KM-30 TENS ELECTRODE | May 23, 2001 | Substantially Equivalent |
| K003228 | K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A | Dec 14, 2000 | Substantially Equivalent |
| K002806 | K-DEFIB/PACE, MODEL KDP-60A | Nov 21, 2000 | Substantially Equivalent |
| K000870 | KM-10 TENS ELECTRODE | Nov 7, 2000 | Substantially Equivalent |
| K993745 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 | Feb 3, 2000 | Substantially Equivalent |
| K991007 | K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 | Aug 23, 1999 | Substantially Equivalent |
| K981737 | K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 | Dec 9, 1998 | Substantially Equivalent |
| K954504 | K-DEFIB/PACE PEDIATRIC ELECTRODE | Nov 17, 1995 | Substantially Equivalent |
| K934692 | K-DEFIB/PACE PEDIATRIC ELECTRODE | Jan 24, 1995 | Substantially Equivalent |